Belt for applying pressure to a bodily organ

ABSTRACT

Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening.

REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/580,033, filed Nov. 1, 2017, which is herebyincorporated herein by reference in its entirety.

The current disclosure generally concerns devices for insertion into apatient's body to apply compression to an organ as a way of treating acondition of the patient. In particular, embodiments of a belt forapplication at least partially around an organ are disclosed.

BACKGROUND

In the treatment of tricuspid valve regurgitation (TR), it has beenproposed to deliver a belt or band around the heart, and particularlyinto the atrioventricular (AV) groove of the heart. When positionedappropriately, the belt is cinched or otherwise tightened around theheart which narrows the tricuspid annulus and relieves the TR condition.To narrow the tricuspid annulus, the belt has to overcome the pressurefrom the heart, which may vary among patients, and which can be thoughtof as an unfortunate side-effect to be managed.

It has been proposed to use sutures to provide tension to the belt whennecessary. Several problems have been noted with that approach. Forexample, when cinched the belt may generate too much pressure againstthe AV groove and/or coronary vessels or other tissues, which canconstrain coronary flow and negatively affect heart function. Further,when a suture attached to a belt is used to cinch, it can be situatedanywhere inside the belt, and move freely both axially and laterally.Control over the suture with respect to the belt, and with respect tobiological structures of the heart, is thus lacking.

Overall, structures and methods for cinching a belt, and for ensuringthat the belt minimizes any risk of coronary compression (e.g.compression of vessels to limit or prevent flow), are needed.

SUMMARY

Among other things, there are disclosed devices and methods for treatingconditions including tricuspid valve regurgitation. Such devices includea band or belt for placement along the AV groove of the heart, which caninclude a heat-settable mesh tube having a first open end and a secondopen end and a lumen passing through the tube from the first open end tothe second open end along a longitudinal axis of the tube. The tube maybe configured longitudinally in a loop so as to be placed around theheart and along the AV groove. A first suture portion is within thetube, and is fixed to the tube adjacent the first open end and extendsthrough the lumen toward the second open end. The first suture portioncan be connected to the tube within the lumen by a plurality of holdingelements so that the first suture portion is longitudinally movablethrough the holding elements with respect to the tube. In someembodiments, a second suture portion is within the tube and parallel toand spaced from the first suture portion. The second suture portion maybe fixed to the tube adjacent the first open end and extend through thelumen toward the second open end. The second suture portion may beconnected to the tube within the lumen by a plurality of holdingelements so that the second suture portion is longitudinally movablethrough the holding elements with respect to the tube. Pulling the firstand/or second suture portions cinches the tube to reduce an area of theloop so that the tube compresses longitudinally in at least selectedlocations along the tube.

In certain embodiments, the first suture portion and second sutureportion each extend through the second open end of the tube to providerespective parts of the first and second suture portions that areoutside the tube and able to be pulled to cinch the tube. Alternatively,the first suture portion and second suture portion can be parts of asingle tensioning suture, having a middle portion between the firstsuture portion and second suture portion. A locking suture may beattached to the middle portion of the tensioning suture. A ring may bewithin the tube and adjacent the second open end, and in such cases thetensioning suture may fold over and through the ring, so that the firstand second suture portions are on one side of the ring and the middleportion is on the other side of the ring. Embodiments of a ring mayinclude a rounded engagement portion around which the tensioning sutureis folded, and/or first and second linear sides that parallel the tubeadjacent the second open end. The first and second linear sides may beconnected to the tube by one or more respective holding elements. Alocking suture can include a plurality of protrusions for use in holdingtension applied to the locking suture and transmitted to the first andsecond suture portions. In one example, the locking suture has a lengthwithin the tube and a portion exiting the tube through the first openend, and the protrusions are on up to the full length of the lockingsuture within the tube and next to the first open end, and are nototherwise on the length of the locking suture within the tube.

Examples of the mesh of the tube are heat-settable materials, such asnitinol. Embodiments include the mesh being heat-set so that when thetube reaches body temperature, its cross section assumes a barbellshape, an ellipse or a flat ribbon shape. Further examples include themesh being heat-set so that when the tube reaches body temperature, itassumes a shape with a first region having a first hoop diameter andfirst cross sectional dimension, and a second region having a secondhoop diameter and second cross sectional dimension. The first hoopdiameter may be greater than the second hoop diameter, and the firstcross sectional dimension may be greater than the second cross sectionaldimension. A medial portion between the first and second regions caninclude a contour adapted to conform to at least part of theatrioventricular groove. Another example can include the mesh beingheat-set so that when the tube reaches body temperature, it assumes asaddle shape having one or more lower rounded contoured regions. Atleast one of the lower rounded contoured regions can be adapted to fitclosely within the AV groove.

The disclosed structures minimize the risk of coronary compression asthe compression belt is tensioned, and methods are disclosed todistribute applied forces of the belt over a sufficiently wide arc ofthe AV groove so as not to compress a coronary artery too much, whilestill achieving a therapeutic benefit in reducing regurgitation in thetricuspid and/or mitral valves. Embodiments of belts as disclosed hereinshould not exert an inward pressure (i.e. toward the heart) that isgreater than coronary arterial pressure during ventricular diastole,when coronary flow is expected to be highest. Such embodiments should beshaped and/or configured to minimize any trauma to adjacent structures(e.g. no sharp edges on the belt), and to minimize risk of sliding on oraround the heart once the belt is placed and cinched (if necessary).Some belt embodiments as disclosed may control the position of a sutureor other tensioning element so as to optimally distribute force orpressure exerted by or otherwise associated with the tensioning element.In particular embodiments, the ends of the belt are configured to beeasily pulled into a delivery catheter or other device (e.g. tapered),if retraction or correction is needed. Some belt embodiments arestretchable or compressible so as to compactly fit over a delivery frameand into a delivery catheter or other device, and will then take on adesired shape or configuration when deployed, which shape orconfiguration will effectively distribute tension, pressure or forces.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a belt according to embodiments disclosedherein.

FIG. 1A is a perspective view of a mesh tube for a belt as in FIG. 1.

FIG. 2 is a cross-sectional view of the belt in FIG. 1, taken along thelines II-II and viewed in the direction of the arrows.

FIG. 3A is a perspective view of a cross-section of an embodiment of abelt of FIG. 1 in a particular set shape.

FIG. 3B is a perspective view of a cross-section of an embodiment of abelt of FIG. 1 in a particular set shape.

FIG. 4 is a perspective view of a cross-section of an embodiment of abelt of FIG. 1 in a particular set shape.

FIG. 5 is a perspective view of a cross-section of an embodiment of abelt of FIG. 1 in a particular set shape.

FIG. 6 is a perspective view of a cross-section of an embodiment of abelt of FIG. 1 in a particular set shape.

FIG. 7 is a plan view of an embodiment of a belt with a singletensioning suture.

FIGS. 8-10 are plan views of embodiments of a belt with two tensioningsuture portions.

FIG. 11 is a plan view of an embodiment of a belt with two tensioningsuture portions with a middle loop.

FIG. 12 is a plan view of an embodiment of a belt with two tensioningsuture portions with a middle loop and additional structure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

While the present disclosure may be embodied in many different forms,for the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the disclosure is thereby intended. Any alterations andfurther modifications in the described embodiments and any furtherapplications of the principles of the present disclosure as describedherein are contemplated as would normally occur to one skilled in theart to which the disclosure relates.

Referring now generally to the drawings, there is shown an embodiment ofa belt 20 for use in applying compression to a bodily organ. As will bediscussed below, belt 20 may be particularly prepared for application tothe atrioventricular (AV) groove of the heart in treatment of tricuspidvalve regurgitation (TR) conditions. While the disclosure herein mayfocus at times on that use and placement, it will be understood that thestructures and methods disclosed may be used for a number of conditions,treatments, implants or purposes.

Belt 20 in the illustrated embodiment is a flexible mesh tube 22 ofbiocompatible material with opposed open ends 24, 26 and a naturaldiameter (i.e. a diameter that the tube has when not under stress orafter being heat-set) around an internal volume or lumen 28 that extendsbetween tapered or otherwise narrowed ends 24 and 26. One or moresutures are connected to belt 20 in order to provide tension to belt 20,as will be discussed further below. Such tension can cinch belt 20 inthe AV groove for treatment of TR. The mesh of tube 20 may be formed ofstrands, wires or fibers 36 separated by interstices 38, or by cutting,etching, stamping or otherwise treating a thin sheet to remove portions,forming interstices 38. The mesh allows belt 20 to stretch lengthwiseunder tension along its length or central axis A to thereby decrease itsdiameter in the area stretched, and to be compressed lengthwise undercompression or relaxation of tension along its length or central axis Ato thereby increase its diameter in the area compressed.

It will be understood that the mesh of tube 22 may be made of a numberof available natural or synthetic sturdy biocompatible materials. In aparticular embodiment, the mesh of belt 20 is of nitinol, for exampleone or more individual nitinol wires (as strand(s) 36) fixed to and/orwound about each other to form interstices 38. Belt 20 in the embodimentillustrated in FIG. 1 has an original cylindrical shape with length Land diameter D measured across the longitudinal axis A. Duringmanufacture, or at least prior to use, embodiments of belt 20 made of aheat-settable materials (e.g. nitinol) can be heat-set into aconfiguration that will be assumed when deployed in the body. In thatexample, belt 20 has its original (e.g. cylindrical) form at roomtemperature, is packed for delivery, and assumes the heat-setconfiguration when inserted into the body and its temperature is orapproaches body temperature.

As a particular example of a desirable heat-set configuration, belt 20is shown in FIG. 3 in a heat-set flat, ribbon shape. The flat ribbonshape may be heat-set into the nitinol mesh so that belt 20 has adesired width w (from side 40 to side 42) in its deployed state to gowith the initial length L. It has been determined what the width wshould be set as indicated below in order to keep the pressure from belt20 from exceeding coronary arterial pressure during ventriculardiastole, for example about 30 mmHg. The stress on a cross section ofbelt 20 for a particular tensile force F is σ₀=F/(tw), where t is thethickness of the mesh of belt 20 and w is the width of belt 20 definedabove. The hoop stress equation relates that stress to a desiredpressure P as σ₀=Pr/t, where t is as defined above and r is the radiusof the AV groove. Setting those representations of cross-sectionalstress equal to each other gives F/tw=Pr/t. Cancelling and rearrangingprovides w=F/Pr. With an experimentally-determined tensile force of 0.4pounds (1.8 N), a vascular pressure of 0.58 psi (30 mmHg), and a radiusof the AV groove of 2 inches (51 mm), the width w of the belt 20 isdetermined to be 0.35 inches (8.9 mm). It will be understood thatdifferent values for the width w of belt 20 will be determined by theabove method for variations with respect to a particular patient, suchas differences in the AV groove radius or differences in vascularpressure. Accordingly, a belt 20 having a width w suited to theparticular patient may be custom-made. That width w is configured byheat-setting belt 20, e.g. one of braided nitinol wires, so that whenheat is applied by the body (i.e. body temperature), belt 20 acquires aconfiguration with width w.

Preferably, belt 20 is heat-set to assume a flattened state, as in theprior example, so as to distribute the forces from the tensioning memberto the belt. Flattening of the original cylindrical cross-section rangesfrom simply ovalizing the cross-section (FIG. 3A, a relatively highwidth w) to making a ribbon-like cross-section in which opposing sides40, 42 of belt 20 are parallel to each other and closely adjacent toeach other (FIG. 3B, a relatively low width w). In FIG. 3A, belt 20 isshown with an oval or elliptical cross section, with edges 44, 46intersecting and separated by a major axis, and a middle portion betweenedges 44, 46, with width w being along or at least substantiallyparallel to a minor axis. In FIG. 3B, likewise edges 44, 46 intersectand are separated by a major axis, and width w is along or parallel to aminor axis. Edges 44, 46 provide locations for one or more sutures fortightening, as will be discussed further below.

In particular embodiments, flattened belt 20 may be heat-set withenlarged, rounded edges 50, 52 on either side of the longitudinal axisA. In cross-section, this example of belt 20 looks like a dog bone or abarbell. As one example, the middle portion 54 of belt 20 between edges50, 52 is flat, having the mesh at least approximately planar in eachside 40, 42 between edges 50, 52, with those sides 40, 42 close to ortouching each other side. Edges 50, 52 are round or curved, for examplehaving a circular or oval cylindrical cross-section. In some illustratedembodiments (e.g. FIG. 4), edges 50, 52 have the same configuration aseach other. Enlarged edges 50, 52 provide additional surface area toengage and grip the underlying tissue in the AV groove. Edges 50, 52,since they are rounded, reduce the potential for sharp corners or othersurfaces that may cause any trauma to adjacent heart tissue. Sinceappendages or lobes of the atria may overhang belt 20 in the AV groove,a lack of such surfaces is preferred.

In another embodiment, belt 20 is heat set with a cross-section thatcreates a region 60 with a larger hoop diameter on one side, and aregion 62 with a tighter/smaller hoop diameter. Region 60 is designedfor placement over the ventricular walls, which are thicker than atrialtissues, and also have a higher chamber pressure. The thickercross-section of region 60 has the advantage of more secure hold to theventricular tissue, and the higher chamber pressure will withstand thatthicker material. Region 62 is designed for placement over the thinnerAV groove and atrial walls with their lower chamber pressure. Thethinner region 62 can allow a medial portion 64 of belt 20 to moreclosely fit in the AV groove. Medial portion 64, as seen in the exampleof FIG. 5, can include a contour 66 in side 42 that conforms to at leastpart of the AV groove.

In another embodiment, belt 20 is heat-set with a ring shape with orapproximating a natural curve of the exterior of the heart, so that belt20 can have a natural location or fit around the heart. For example, animage of the heart may be taken so as to model the organ, and thatimaging used to create a curve in belt 20, which is then heat-set intobelt 20. Such an embodiment eases deployment, as belt 20 will assume theshape of the heart when deployed. A belt 20 in that shape will fitbetter over the heart, akin to fitting an oval peg into a hole withcorresponding size and shape, and will conform better to the contours ofthe heart prior to a final tensioning of belt 20.

In another embodiment, belt 20 is heat-set with a three-lobed or saddleshape. FIG. 6 is an example cross sectional shape that would allow thepassage of three sutures, e.g. one along each lobe, so as to distributethe load laterally along the AV groove. The shape addresses the factthat the AV groove itself does not lie in a single plane. A shape ofbelt 20 as in FIG. 6 allows it to more naturally sit in the AV grooveupon deployment. Further, when used with three tensioning sutures, thelobes keep the sutures separated and distribute the compressive forcesapplied by the sutures. In that example, belt 20 has an upper flatregion 70 and one or more lower contoured regions, e.g. two side lobes72 and a middle lobe 74. Middle lobe 74 is rounded, e.g.part-cylindrical or a rounded ridge, that is adapted to fit within, andpreferably closely within, the AV groove. Side lobes 72 are rounded,e.g. with at least part having essentially the same curvature as middlelobe 74, and edges 76 are also rounded. Such edge regions, as notedabove with respect to (dog-bone version), provide more secure engagementwithout sharp corners. More generally, the pathway of belt 20 can beheat set to a non-planar three-dimensional shape that better traces thepathway of the AV groove in the heart.

In any of these embodiments, belt 20 may be heat-set to provide agreater width w of belt 20 for regions of the belt that are to be placedover areas of the heart where arteries are (more likely) to passunderneath. That greater width allows for a relatively smaller pressurein that area of belt 20 when tensioned, and such an area should be overregions of the heart where arteries pass. Belt 20 may be narrower inwidth in portions that will lie over or near the tricuspid annulus ofthe heart. That narrower width may provide a relatively greater pressurein that area of belt 20 when tensioned, and thus directs that greaterpressure where needed to treat tricuspid regurgitation.

In any of the embodiments of belts disclosed herein, tension is appliedby one or more sutures through the belt. By “sutures” is meant not onlythe common definition, but any biocompatible line or filament havingflexibility and tensile strength sufficient to be passed through a beltfor use in procedures such as TR treatment and pull it in tension whendeployed, as discussed herein. Further, “sutures” means not only whollyseparate items but also portions of one or more such items. Pulling orotherwise placing the suture(s) in tension applies compression to thebelt, thereby applying compression to the AV groove of the heart.

In embodiments in which only one tensioning suture is attached orotherwise connected to belt 20 (e.g. FIG. 7), the suture 78 may floatwithin belt 20 through lumen 28. One end of the tensioning suture 78 isfixed to belt 20 at or near one end 24 of belt 20 (and a lockingmechanism M attached or otherwise connected to belt 20) in particularembodiments. The suture 78 passes through lumen 28 and out of end 26 ofbelt 20 and through the locking mechanism M. The tensioning suture 78within belt 20 can move both axially and laterally with respect to belt20. Pulling on the end of the tensioning suture 78 that passes throughthe locking mechanism, with the other end fixed to belt 20, moves partof the suture 78 through belt 20. End 24 is pulled along axis A alongwith suture 78, to reduce the length of belt 20 and placing it intension. Activation of the locking mechanism M holds the suture 78, andbelt 20, with that tension around the heart.

In the embodiment illustrated in FIG. 8, belt 20 includes two parallelsutures or suture portions 80, 82 within it to provide tension. It hasbeen found that the use of two sutures 80, 82 is more effective inproviding steady tension to belt 20, and in distributing the pressure orforce when cinching or tightening belt 20 around the heart, than can bedone with a single suture floating within belt 20. For example,application of force through two separated sutures reduces or eliminatesrisk of turning or pivoting of belt 20 during tightening or cinching,e.g. by turning belt around an edge (e.g. 44, 46, 50 or 52) so that flatbelt 20 rises or stands on one edge. It has also been found that use oftwo sutures 80, 82 with belt 20 is more effective when sutures 80, 82are confined laterally, i.e. maintained apart from each other. It hasbeen found that two floating sutures tend to stay together, due tominimized potential energy, or being pulled together during deploymentor cinching of belt 20. When the sutures stay together, they tend tobehave like a single, thicker suture, which loses the force applicationand distribution and other benefits of having two sutures.

Sutures 80, 82 are attached to belt 20 in locations opposed to eachother across the longitudinal axis of belt 20, and in the illustratedembodiment, sutures 80, 82 are attached to the inside of belt 20. Inembodiments in which belt 20 is heat-set to a particular shape, sutures80, 82 are placed after heat-setting. A series of holding elements 84surround sutures 80, 82 in various locations along belt 20. In aparticular embodiment, elements 84 are threads or filaments that tiearound the respective suture 80, 82 and through the mesh of belt 20. Forexample, a holding element 84 in the form of a filament 86 is threadedthrough the mesh, around suture 80, and back through mesh, one or moretimes, and then is knotted, heat-fused, or otherwise secured. In theillustrated embodiment, filament 86 is threaded or looped around suture80 at least twice, and secured at or adjacent belt 20, e.g. on an outersurface of belt 20. It will be understood that securing (e.g. byknotting) filament 86 with respect to itself and to belt 20 retains someslack or flexibility in filament 86 to form an opening or passage 88through each holding element 84 that allow suture 80 to movelongitudinally through the passages 88 of respective holding elements 84with minimal resistance. As a particular case, a respective tube foreach respective tensioning suture 80, 82 may be placed through the lumenof belt 20, similar to tube 100 shown in FIG. 10. The respectivetensioning suture extends through its respective tube either initiallyor by being threaded through after the tube is placed within belt 20.Filaments 86 can be threaded through the mesh of belt 20 and around thetube, for example twice or more, cinched to be snug around the tube andknotted or otherwise secured, to form securing elements 84. Then thetube may be slid out from elements 84 over the respective tensioningsuture. The snug fit of elements 84 around the tube makes tying orfixing the elements easier, and ensures that the elements are slack withrespect to the tensioning suture when the tube is removed. Similar oridentical holding or securing elements 84 are present for suture 82.

In other embodiments, holding elements may be or include rings, tubingor sheath attached to belt 20. Filaments as discussed above behave asrings. In an example of belt 20 made of nitinol wires in a mesh,internal guide rings (92 in FIG. 9) may be formed using the individualwire(s) that form the mesh of belt 20 (e.g. such rings may be createdwhen the mesh for belt 20 is formed). Rings 92 have an opening orpassage 94 sized to allow suture 80 or 82 to pass through ringslongitudinally with minimal resistance. The metallic surface of rings 92may provide significantly less resistance to longitudinal passage ofsutures 80, 82 than filament holding elements 84, particularly if themetal (e.g. nitinol wires) are smoothed, as is indicated for use in belt20 so as to limit or eliminate damage or irritation to adjacent tissue.In other embodiments, a tube or sheath 100 may be attached to the insideof belt 20 (e.g. FIG. 10), in similar locations to individual filamentholding elements 84 or ring holding elements 92, which have a passagesized to allow suture 80 or 82 to pass through rings longitudinally withminimal resistance. Several individual tubes may be placed within belt20 and separated by gaps from each other, particularly if such tubes areless longitudinally compressible than belt 20, or if a single tube 100is used as a holding element, such a tube should be compressible so asnot to limit the cinching of belt 20 when placing it in tension.

Securing or holding elements 84 are evenly spaced, in the illustratedembodiment, along belt 20. Because sutures 80, 82 are intended to remainin tension or essentially linear in holding elements 84 along belt 20,holding elements 84 may be spaced relatively far from each other, e.g.up to 5 millimeters, up to 10 millimeters, up to 15 millimeters, up to20 millimeters from each other in particular embodiments, or closeenough to each other so that any slack that may exist in one or both ofsuture 80, 82 does not allow one of sutures 80, 82 to touch the otherwhen belt is being deployed. Further, the locations of holding elements84 are shown in one embodiment as staggered along sutures 80, 82, i.e. aplane perpendicular to the longitudinal axis of belt 20 through oneholding element 84 holding one suture 80 will pass between holdingelements 84 holding the other suture 82, and in a particular embodimentwill be halfway between holding elements 84 holding the other suture 82(e.g. FIG. 8). That staggered condition allows belt 20 to be folded,compressed or otherwise packed into a delivery device with holdingelements 84 offset from each other, providing a lower profile for thedelivery device. In other embodiments, holding elements 84 may besymmetric or only very slightly offset (e.g. by 1-3 millimeters, so thatthe above noted plane through a holding element with suture 80 may passimmediately next to a holding element with suture 82) in belt 20. Insuch a case, tension by sutures 80, 82 is applied to belt 20, viaholding elements 84, at or near the same locations on sides 40, 42 ofbelt 20.

In other embodiments, one or both of sutures 80, 82 may be woven throughthe mesh of belt 20 along two lines each lateral of the longitudinalaxis of belt 20. In one example, suture 80 may be fixed at one end 24 ofthe interior of belt 20, passed out through the mesh of belt 20 and runalong the outside of belt 20 for a length, then passed back through themesh to the inside of belt 20 for a length (which may be the same or adifferent length as was run along the outside of belt 20). That weavingcontinues through the length of belt 20. Suture 82 may be similarly oridentically woven through the other side of belt 20. It has been foundthat such weaving produces relatively high friction forces betweensuture(s) 80, 82 and belt 20, and when suture(s) 80, 82 are cinched, thetension provided to belt 20 may not be homogeneous, so that part of belt20 contracts around the heart, while other parts may remain relativelyloose. Thus, weaving suture(s) 80, 82 through belt 20 may be effectiveunder certain circumstances, but other embodiments disclosed hereinoperate in a more effective fashion.

In another embodiment, shown in FIG. 11, a belt 20 is shown that issimilar or identical to embodiments of belt 20 described above,including mesh tube 22 with narrowed ends 24, 26. In this embodiment, asingle suture S extends through belt 20, with a first suture portion 80extending along one side or edge of belt 20 and a second suture portion82 extending along an opposite side or edge of belt 20. As with otherbelt embodiments described herein, suture S is fixed to tube 22 at end24, e.g. an end of suture portion 80 and an end of suture portion 82 arerespectively fixed to tube 22, as indicated in FIG. 11, or to a lockingmechanism M adjacent or connected to tube 22. From those fixed ends,each suture portion 80, 84 runs toward end 26, and are held to tube 22by one or more holding elements 84, as discussed above. When sutureportions 80, 82 are near or reach end 26 in this embodiment, suture Sloops back through lumen 28 of belt 20 to form loop 85. Loop 85 in thisembodiment extends through lumen 28 and out through end 24 (and throughlocking mechanism M, if present) to an exterior of tube 22 of belt 20.Loop 85 can be connected to a tensioning line T, as by a hook, grip orother structure, that may be part of a system for delivering belt 20.Following deployment of belt 20, as generally described below,tensioning line T can preferably be disengaged from loop 85 andwithdrawn. This embodiment provides redundancy, so that if one of sutureportions 80, 82 fails, the other suture portion remains to providetension to belt 20.

In another embodiment, belt 20 (FIG. 12) is configured the same asembodiment(s) above, with holding elements 184 that are similar oridentical to holding elements 84 described above. It will be understoodthat belt 20 may be made, shaped and/or configured as described abovewith respect to particularly-shaped or set embodiments. A first sutureor suture portion 180 passes through holding elements 184 along one side140 of belt 20, and a second suture or suture portion 182 passes throughholding elements 184 along another side 142 of belt 20, e.g. a sideopposite from suture or suture portion 180 across the longitudinal axisA of belt 20. A locking suture 210 is connected to suture portions 180,182 at or adjacent one end 226 of belt 20, and the suture portions 180,182 pass through a ring 212 at or adjacent that end 226 of belt 180.

In the illustrated embodiment, suture portions 180, 182 are part of asingle tensioning suture S. Suture portions 180, 182 are each fixed toend 224 of belt 20 (e.g. by a blanket stitch), as described above withrespect to suture 80, 82. Suture portion 180 passes through holdingelements 184 on one side of belt 20 (e.g. the top as seen in FIG. 12),then a central loop 214 of the suture S passes through ring 212 at ornear the other end 226 of belt 20, and the rest of the suture S passesthrough holding elements 184 on the other side of belt 80 (e.g. thebottom as seen in FIG. 12) and is fixed at end 224 of belt 20. Loop 214that passes through ring 212 is fixed to an end 222 of locking suture210, so that the tensioning suture S folds over a portion of ring 212(i.e. bending 180 degrees around and through ring 212), with portions80, 82 on one side of ring 212 and loop 214 on the other. It will beunderstood that in other embodiments suture portions 80, 82 may beseparate tensioning sutures, each of which pass through ring 212 asdescribed above and attach to locking suture 210.

Locking suture 210 in the illustrated embodiment includes a series ofknots, beads or other protrusions 230, which in the illustratedembodiment are evenly spaced along the whole length of suture 210 withinbelt 220 and into a locking mechanism M (as described above). In otherembodiments, protrusions 230 may be present only in part of suture 210,e.g. of the part of locking suture 210 within belt 220 and into lockingmechanism M, at least the one-third to one-half that is furthest fromring 212. It has been found that the tensioned or cinched belt (e.g.belt 20) may need to have a length between 60 and 80 percent of theinitial length L of the belt, and so a length of suture 210 (e.g.between 80 and 40 percent of the initial length of suture 210 within thebelt) will have to pass out of the belt and to or through a lockingmechanism M. Accordingly, placing protrusions on at least the 40 to 80percent of suture 210 that is adjacent mechanism M and entering belt 20,and therefore has the potential to be pulled through the end of the beltand a locking mechanism, is advantageous.

Ring 212 in the illustrated embodiment has a rounded (e.g. circular)portion 250 over which tensioning sutures or suture portions 180, 182are folded, and two linear sides 252, 254 that join to each other and torounded portion 250. Ring 212 may be made of a biocompatible wire orother sturdy material, and is relatively inflexible so as to be able toeffectively transfer tension from locking suture 210 to tensioningsuture portions 180, 182. The exterior surface 256 of ring 212 isrounded (e.g. made of wire that is circular in cross section) and smoothin certain embodiments, so as to reduce friction between ring 212 andtensioning suture portions 180, 182 during use. It has been found inexperimental testing that the cross-sectional diameter of wire used inembodiments of ring 212 has a substantial effect on friction betweenring 212 and suture portions 180, 182, and that for a suture of 0.35millimeter diameter and made of ultra-high molecular weight polyethylene(UHMWPE), wire used to make ring 212 should have a diameter of 0.021inches or larger.

Sides 252 and 254 are unitary or monolithic with rounded portion 250,and are linear in this embodiment, joining with each other at an apex258. The linear nature of sides 252, 254 is intended to fit closely withthe narrowing sides 240, 242 of belt 20 at end 226 of belt 20, and in aparticular embodiment the angle between sides 252, 254 at apex 258 isbetween 5 and 30 degrees. Sides 252, 254 may be initially separate andbe joined at apex 258, as by welding, adhesives or other techniques, orthey may be formed joined with each other and with rounded portion 250.Ring 212 is held to the narrowing sides 240, 242 of belt 20 by holdingelements 260, which may be similar or identical to embodiments ofholding elements 84 described above.

The embodiment of belt 20, with ring 212, provides several advantages,including low friction between the tensioning suture 180, 182 and belt20, and a locking suture 210 having protrusions 230 that has a low riskof becoming stuck to belt 20. The design will permit cinching of belt 20up to about 50 percent of the original length of belt 20, which willprovide sufficient decrease of tricuspid annulus in TR treatment. Also,as noted above with respect to FIG. 11, a failure in one suture 180 or182, leaves the other to provide tension to belt 20.

Use of belt 20 will now be discussed in the context of placement in oralong a patient's AV groove and tightening, for treatment of TR or otherconditions. It will be understood that use of the disclosed structure inother locations or contexts is possible. Reference in the followingdiscussion is particularly to the embodiment in FIG. 12. However, itwill be understood that the methods described below are generallyapplicable to other embodiments of belt 20 described herein, theprincipal difference being the lack of ring 212 and/or a locking suture210.

Belt 20 is delivered to the AV groove, as by a delivery system (notshown) that can include an introducer as disclosed in PCT/US2017/058245,filed Oct. 25, 2017, which is incorporated by reference herein in itsentirety. Belt 20 exits the delivery system and is looped around theheart, and situated in the AV groove. Belt 20 and suture portions 180,182 thus circle around the heart.

When placement of belt 20 is determined to be satisfactory, the userproceeds to tighten belt 20 to decrease tricuspid annulus on the heartaround the AV groove. The user pulls on locking suture 210 using anappropriate tool (not shown), so that locking suture begins to exit end224 of belt 20 and move through locking mechanism M. As locking suture210 is pulled, loop 214 is also pulled, and tension in locking suture210 is passed around ring 212 to tensioning suture portions 180, 182.Suture portions 180, 182 are thus pulled through their respectiveholding elements 184. Pulling suture portions 180, 182 reduces theradius of suture portions 180, 182 around the heart, forcing belt 20inward against the heart, and the respective ends of suture portions180, 182 that are fixed to end 224 of belt 20 compress the length ofbelt 20. As the length of belt 20 is compressed, the mesh of belt 20transmits that compression into some expansion in width, providingflexibility so as to limit or reduce pressure exerted on coronaryarteries or other structures.

Locking suture 210 is pulled until the desired amount of tricuspidannulus decrease is achieved. In particular embodiments, as noted above,that amount is achieved with a reduction in length of belt 20 to up to60 percent of the original length of belt 20. Once the cinching ortightening is complete, locking mechanism M is activated to hold lockingsuture 210 in the tensioned condition. Removal of delivery and othertools and completion of the procedure can then be performed.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly selected embodiments have been shown and described and that allequivalents, changes, and modifications that come within the spirit ofthe disclosures as defined herein or by the following claims are desiredto be protected. It will be understood that features describedparticularly with respect to one or more specific structures orembodiments may be incorporated into or otherwise used with otherstructures or embodiments as disclosed herein.

The following numbered clauses set out specific embodiments that may beuseful in understanding the present invention:

1. A belt for placement along the atrioventricular groove of the heart,comprising:

a mesh tube having a first open end and a second open end and a lumenpassing through the tube from the first open end to the second open endalong a longitudinal axis of the tube, the tube configuredlongitudinally in a loop so as to be placed around the heart and alongthe atrioventricular groove;

a first suture portion within the tube, the first suture portion fixedto the tube adjacent the first open end and extending through the lumentoward the second open end, the first suture portion connected to thetube within the lumen by a plurality of holding elements so that thefirst suture portion is longitudinally movable through the holdingelements with respect to the tube;

a second suture portion within the tube and parallel to and spaced fromthe first suture portion, the second suture portion fixed to the tubeadjacent the first open end and extending through the lumen toward thesecond open end, the second suture portion connected to the tube withinthe lumen by a plurality of holding elements so that the second sutureportion is longitudinally movable through the holding elements withrespect to the tube;

wherein pulling the first and second suture portions cinches the tube toreduce an area of the loop so that the tube compress longitudinally inat least selected locations along the tube.

2. The belt of clause 1, wherein the first suture portion and secondsuture portion each extend through the second open end of the tube toprovide respective parts of the first and second suture portions thatare outside the tube and able to be pulled to cinch the tube.

3. The belt of any of clauses 1-2, wherein the first suture portion andsecond suture portion are parts of a single tensioning suture, having amiddle portion between the first suture portion and second sutureportion, and further comprising a locking suture attached to the middleportion of the tensioning suture.

4. The belt of any of clauses 1-3, further comprising a ring within thetube and adjacent the second open end, wherein the tensioning suturefolds over and through the ring, wherein the first and second sutureportions are on one side of the ring and the middle portion is on theother side of the ring.

5. The belt of clause 4, wherein the ring includes a rounded engagementportion around which the tensioning suture is folded.

6. The belt of clause 4, wherein the ring includes first and secondlinear sides that parallel the tube adjacent the second open end, thefirst linear side connected to the tube by at least one holding element,and the second linear side connected to the tube by at least one holdingelement.

7. The belt of any of clauses 3-6, wherein the locking suture includes aplurality of protrusions for use in holding tension applied to thelocking suture and transmitted to the first and second suture portions.

8. The belt of clause 7, wherein the locking suture has a length withinthe tube and a portion exiting the tube through the first open end, andwherein the protrusions are on up to the full length of the lockingsuture within the tube and next to the first open end, and are nototherwise on the length of the locking suture within the tube.

9. The belt of any of clauses 1-8, wherein the mesh is nitinol.

10. The belt of any of clauses 1-9, wherein the mesh is heat-set so thatwhen the tube reaches body temperature, its cross section assumes abarbell shape.

11. The belt of any of clauses 1-9, wherein the mesh is heat-set so thatwhen the tube reaches body temperature, its cross section assumes anelliptical or oval shape.

12. The belt of any of clauses 1-9, wherein the mesh is heat-set so thatwhen the tube reaches body temperature, it assumes a flat ribbon shape.

13. The belt of any of clauses 1-9, wherein the mesh is heat-set so thatwhen the tube reaches body temperature, it assumes a shape with a firstregion having a first hoop diameter and first cross sectional dimension,and a second region having a second hoop diameter and second crosssectional dimension, and wherein the first hoop diameter is greater thanthe second hoop diameter, and the first cross sectional dimension isgreater than the second cross sectional dimension.

14. The belt of clause 13, wherein a medial portion between the firstand second regions includes a contour adapted to conform to at leastpart of the atrioventricular groove.

15. The belt of any of clauses 1-9, wherein the mesh is heat-set so thatwhen the tube reaches body temperature, it assumes a saddle shape havingone or more lower rounded contoured regions, and wherein at least one ofthe lower rounded contoured regions is adapted to fit closely within theatrioventricular groove.

16. The belt of any of clauses 1-15, wherein the two suture portions areeach part of a respective separate suture.

17. The belt of any of clauses 1-16, wherein the two suture portions areconnected to form a loop.

18. The belt of clause 17, wherein the loop is connected to an elongatedelement at least partially exterior to the belt, the elongated elementbeing one of a locking suture and a delivery filament.

Structures or other features specified in the above clauses may beincluded singly or in any combination in the inventive devices, alongwith other structures or features described above with respect to anyembodiment.

1. A belt for placement along the atrioventricular groove of the heart,comprising: a mesh tube having a first open end and a second open endand a lumen passing through the tube from the first open end to thesecond open end along a longitudinal axis of the tube, the tubeconfigured longitudinally in a loop so as to be placed around the heartand along the atrioventricular groove; a first suture portion within thetube, the first suture portion fixed to the tube adjacent the first openend and extending through the lumen toward the second open end, thefirst suture portion connected to the tube within the lumen by aplurality of holding elements so that the first suture portion islongitudinally movable through the holding elements with respect to thetube; a second suture portion within the tube and parallel to and spacedfrom the first suture portion, the second suture portion fixed to thetube adjacent the first open end and extending through the lumen towardthe second open end, the second suture portion connected to the tubewithin the lumen by a plurality of holding elements so that the secondsuture portion is longitudinally movable through the holding elementswith respect to the tube; wherein pulling the first and second sutureportions cinches the tube to reduce an area of the loop so that the tubecompress longitudinally in at least selected locations along the tube.2. The belt of claim 1, wherein the first suture portion and secondsuture portion each extend through the second open end of the tube toprovide respective parts of the first and second suture portions thatare outside the tube and able to be pulled to cinch the tube.
 3. Thebelt of claim 1, wherein the first suture portion and second sutureportion are parts of a single tensioning suture, having a middle portionbetween the first suture portion and second suture portion, and furthercomprising a locking suture attached to the middle portion of thetensioning suture.
 4. The belt of claim 3, further comprising a ringwithin the tube and adjacent the second open end, wherein the tensioningsuture folds over and through the ring, wherein the first and secondsuture portions are on one side of the ring and the middle portion is onthe other side of the ring.
 5. The belt of claim 4, wherein the ringincludes a rounded engagement portion around which the tensioning sutureis folded.
 6. The belt of claim 4, wherein the ring includes first andsecond linear sides that parallel the tube adjacent the second open end,the first linear side connected to the tube by at least one holdingelement, and the second linear side connected to the tube by at leastone holding element.
 7. The belt of claim 3, wherein the locking sutureincludes a plurality of protrusions for use in holding tension appliedto the locking suture and transmitted to the first and second sutureportions.
 8. The belt of claim 7, wherein the locking suture has alength within the tube and a portion exiting the tube through the firstopen end, and wherein the protrusions are on up to the full length ofthe locking suture within the tube and next to the first open end, andare not otherwise on the length of the locking suture within the tube.9. The belt of claim 1, wherein the mesh is nitinol.
 10. The belt ofclaim 1, wherein the mesh is heat-set so that when the tube reaches bodytemperature, its cross section assumes a barbell shape.
 11. The belt ofclaim 1, wherein the mesh is heat-set so that when the tube reaches bodytemperature, its cross section assumes an elliptical or oval shape. 12.The belt of claim 1, wherein the mesh is heat-set so that when the tubereaches body temperature, it assumes a flat ribbon shape.
 13. The beltof claim 1, wherein the mesh is heat-set so that when the tube reachesbody temperature, it assumes a shape with a first region having a firsthoop diameter and first cross sectional dimension, and a second regionhaving a second hoop diameter and second cross sectional dimension, andwherein the first hoop diameter is greater than the second hoopdiameter, and the first cross sectional dimension is greater than thesecond cross sectional dimension.
 14. The belt of claim 13, wherein amedial portion between the first and second regions includes a contouradapted to conform to at least part of the atrioventricular groove. 15.The belt of claim 1, wherein the mesh is heat-set so that when the tubereaches body temperature, it assumes a saddle shape having one or morelower rounded contoured regions, and wherein at least one of the lowerrounded contoured regions is adapted to fit closely within theatrioventricular groove.
 16. The belt of claim 1, wherein the two sutureportions are each part of a respective separate suture.
 17. The belt ofclaim 1, wherein the two suture portions are connected to form a loop.18. The belt of claim 17, wherein the loop is connected to an elongatedelement at least partially exterior to the belt, the elongated elementbeing one of a locking suture and a delivery filament.
 19. A belt forplacement along the atrioventricular groove of the heart, comprising: amesh tube having a first open end and a second open end and a lumenpassing through the tube from the first open end to the second open endalong a longitudinal axis of the tube, the tube configuredlongitudinally in a loop so as to be placed around the heart and alongthe atrioventricular groove; a first suture portion within the tube, thefirst suture portion connected to the tube within the lumen by a firstplurality of holding elements so that the first suture portion islongitudinally movable through the holding elements with respect to thetube; a second suture portion within the tube and laterally spaced fromthe first suture portion, the second suture portion connected to thetube within the lumen by a second plurality of holding elements so thatthe second suture portion is longitudinally movable through the holdingelements with respect to the tube; wherein pulling the first and secondsuture portions cinches the tube to reduce an area of the loop so thatthe tube compress longitudinally in at least selected locations alongthe tube.
 20. A method of placing a belt along the atrioventriculargroove of the heart, comprising: positioning a mesh tube in the form ofa loop around the heart and along the atrioventricular groove, the meshtube having a first open end and a second open end and a lumen passingthrough the tube from the first open end to the second open end along alongitudinal axis of the tube; pulling a first suture portion within thetube so that the first suture portion moves longitudinally through afirst plurality of holding elements connecting the first suture portionto the tube; pulling a second suture portion within the tube so that thesecond suture portion moves longitudinally through a second plurality ofholding elements connecting the second suture portion to the tube; andwherein said pulling a first suture portion and said pulling a secondsuture portion cinches the tube to reduce an area of the loop andlongitudinally compresses the tube in at least selected locations alongthe tube.